Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study

NCT07479381 | Terminated

• 1 other identifier: HH-PRT-0006
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate a blood-based screening test for Colorectal Cancer (CRC).

Conditions

Colorectal Cancer (Diagnosis)

Keywords

Colorectal cancer; Cancer; Diagnostic test; Blood test; Oncology

Outcome Measures

Primary Outcomes (1)

• Establish predictive value

  1\. Establish the predictive value of the Harbinger test for colorectal cancer (CRC) per test readout category.

  14 month

Secondary Outcomes (2)

• Establish incidence

  14 months

• Establish readout distribution

  14 months

Study Arms (2)

Cohort 1: Prospective Cohort

Participants with average risk CRC and a positive mt-sDNA test within 12 months of the study blood draw and who are scheduled and intending to undergo a diagnostic colonoscopy within 60 days of consent as part of standard care.

Cohort 2: Confirmed Case Cohort

Participants with a confirmed colorectal cancer diagnosis at informed consent and who are treatment-naïve for the current malignancy.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants 45 years of age or older with: average risk colorectal cancer (CRC) and a positive result on a multitarget stool DNA test, and participants with a confirmed CRC diagnosis.

You may qualify if:

• Provide written or electronic informed consent, according to local guidelines, signed and dated by the Participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
• Age 45 or older at time of consent
• Documented positive result from a mt-sDNA test obtained as part of routine clinical care within 12 months of blood draw
• Scheduled and intends to undergo a diagnostic colonoscopy within 60 days of consent as part of standard care
• Considered by a physician as being of average risk for CRC
• Willing to provide an investigational blood draw prior to undergoing bowel preparation administration and colonoscopy.
• Provide written or electronic informed consent, according to local guidelines, signed and dated by the Participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
• Age 45 or older at time of consent
• Has a confirmed CRC diagnosis within 90 days prior to signing the informed consent form, based on standard diagnostic procedures
• Must remain treatment-naïve for the current malignancy (no surgical resection, neoadjuvant chemotherapy, or radiation therapy has occurred since diagnosis)

You may not qualify if:

• Undergoing colonoscopy for investigation of symptoms such as rectal bleeding, blood in stool, or significant recent changes in stool habits
• History of CRC or AA diagnosed prior to the index mtsDNA positive test result
• History of any malignancy (patients who have undergone surgical removal of skin basal cell or squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of informed consent)
• Has been diagnosed with a condition associated with a high risk of CRC (including inflammatory bowel disease (IBD), chronic ulcerative colitis, Crohn's disease, or familial adenomatous polyposis) or has a family history of CRC, defined as having a first-degree relative (parent, sibling, or child) with a CRC diagnosis at any age
• Has been diagnosed with a relevant familial (hereditary) cancer syndrome that places them above average risk of CRC such as hereditary nonpolyposis CRC syndrome (or Lynch syndrome), Peutz-Jeghers syndrome, MYH-associated polyposis, Gardner's syndrome, Turcot's (or Crail's) syndrome, Cowden's syndrome, juvenile polyposis, Cronkhite-Canada syndrome, neurofibromatosis, or familial hyperplastic polyposis
• Is suffering from any febrile illness defined as a temperature \>101.5°F within 48 hours preceding the blood draw
• Participant is pregnant (self-reported)
• Recipient of an organ transplant, blood transfusion within 120 days, or prior non-autologous (allogeneic) bone marrow or stem cell transplant (Participants with a corneal transplant can be considered for study entry)
• Inability or unwillingness to comply with study procedures or follow-up requirements
• Previous or current participation in any study sponsored by, or employment with, Harbinger Health
• Participation in a clinical research study sponsored by an external organization which may interfere with study procedures or outcomes
• Has any condition that in the opinion of the Investigator should preclude participation in the study
• Has a history of any malignancy (patients who have undergone surgical removal of skin basal cell or squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of informed consent for the study)
• Is suffering from any febrile illness defined as a temperature \>101.5°F within 48 hours preceding the blood draw
• Participant is pregnant (self-reported)

Sponsors & Collaborators

• Harbinger Health: lead

Study Sites (1)

Aton Health

Kansas City, Missouri, 64114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Colorectal Neoplasms; Disease; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 18, 2026
• Study Start: March 20, 2026
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)